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NAC
NAC (N-acetylcysteine) is a mucolytic and antioxidant agent that breaks down mucus viscosity and replenishes intracellular glutathione to reduce oxidative stress.
NAC (N-acetylcysteine) is a mucolytic and antioxidant agent that breaks down mucus viscosity and replenishes cellular glutathione to reduce oxidative stress. Used for Middle ear effusion and otitis media with effusion, Cerumen impaction and ear wax buildup.
At a glance
| Generic name | NAC |
|---|---|
| Also known as | N-acetylcysteine, acetylcysteine, N-acetyl-L-cysteine, N-acetyl cystien, N-Acetylcysteine |
| Sponsor | Otologic Pharmaceutics, Inc. |
| Drug class | Mucolytic agent and antioxidant |
| Target | Disulfide bonds in mucoproteins; glutathione synthesis pathway |
| Modality | Small molecule |
| Therapeutic area | Otology / Respiratory / General |
| Phase | FDA-approved |
Mechanism of action
NAC works through two primary mechanisms: it directly cleaves disulfide bonds in mucoproteins, reducing mucus thickness and improving clearability in the respiratory tract; additionally, it serves as a glutathione precursor, restoring cellular antioxidant capacity and reducing inflammation. This dual action makes it useful in conditions characterized by excessive or thick mucus production and oxidative damage.
Approved indications
- Ototoxicity prevention in patients receiving ototoxic medications (e.g., aminoglycosides, cisplatin)
- Chronic bronchitis and mucolytic therapy
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Rash
- Unpleasant odor (sulfur-like)
Key clinical trials
- Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer (PHASE2)
- Prospective Validation of Ataraxis AI Test for Predicting Treatment Response in Neoadjuvant Breast Cancer
- Effects of NAC on Symptoms of CHR Patients (NA)
- Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine (PHASE4)
- Neoadjuvant Chemotherapy Before Surgery vs Surgery Alone for UTUC: A Randomized Trial (PHASE2)
- Glutathione in Mild Cognitive Impairment (EARLY_PHASE1)
- Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients (PHASE2)
- A Study to Explore if Long-term Use of Mucinex Can Help With Symptoms in Patients With Stable Chronic Bronchitis. (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NAC CI brief — competitive landscape report
- NAC updates RSS · CI watch RSS
- Otologic Pharmaceutics, Inc. portfolio CI